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Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer (Sonoma)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00826982
First Posted: January 22, 2009
Last Update Posted: May 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic
  Purpose
The major goal of this project is to reduce unnecessary pancreatic resections, namely resection in those patients with non-regional lymph node metastatses that cannot be cured with surgical resection. By combined minimally invasive methods for non-surgical biopsy and highly sensitive molecular assays for cancer cells, we believe we can increase the ability to detect distant lymph node metastases prior to surgical resection, and direct those patients for more appropriate therapy (including possible neo-adjuvant chemotherapy with or without surgery). We hypothesize that the combination of EUS-FNA and polymerase chain reaction (PCR) of a multimarker panel will increase the sensitivity for malignant lymph nodes compared with EUS-FNA cytology in patients with pancreatic ductal adenocarcinoma.

Condition
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Michael Wallace, Mayo Clinic:

Primary Outcome Measures:
  • To determine the if molecular biomarkers increase the sensitivity by at least 5% for detection of malignant lymph nodes in patients with pancreatic ductal adenocarcinoma as compared to EUS-FNA cytology of lymph nodes alone. [ Time Frame: End of study ]

Secondary Outcome Measures:
  • To determine the degree of RNA overexpression of pancreas cancer specific biomarkers in the pre-operative fine needle aspirate of lymph nodes and tumors of patients with pancreatic cancer using a set of pancreas cancer specific biomarkers [ Time Frame: End of study ]

Enrollment: 90
Study Start Date: January 2008
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic Cancer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care
Criteria

Inclusion Criteria:

  • Patients with a mass in the pancreas suspicious for adenocarcinoma without biopsy proven distant metastases.
  • Patients who are scheduled for clinically indicated EUS

Exclusion Criteria:

  • Patients who are medically unfit for endoscopic sedation or surgery due to severe comorbid disease such as uncontrolled coronary disease, or oxygen dependant pulmonary disease.
  • Patients who have any other malignancy other than basal cell carcinoma within the past 5 years.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826982


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Michael Wallace, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00826982     History of Changes
Other Study ID Numbers: 07-006640
MCR SPORE (CA102701-05DJ)
ACG (FNDT-1)
First Submitted: January 20, 2009
First Posted: January 22, 2009
Last Update Posted: May 16, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasm Micrometastasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes